SureStep Maker Ordered to Pay Fine

On December 15, 2000, after a three-year government investigation, LifeScan, Inc., a Johnson & Johnson company, entered a plea of guilty to three misdemeanor charges relating to a federal government investigation of its SureStep Blood Glucose Meter. LifeScan will pay a fine of $29.4 million and an additional $30.6 million in civil settlement to the government.

Problems discovered with the SureStep included:

A software problem that caused SureStep users with BGs higher than 500 mg/dl to sometimes receive an “Er 1” (Error 1) message instead of an “HI” warning. This error occurred in SureStep models made before August 1997. This error was corrected after August 1997.

Test strip problems for strips manufactured before March 1998, which could yield false low test results if the strip containing the blood sample was not completely inserted into the meter. This error message affected the SureStep meter and the SureStep Pro system used in hospitals and was corrected after March 1998.

In June 1998, LifeScan offered to replace all affected SureStep meters free of charge.

According to a December 15, 2000 Johnson and Johnson press release, through this settlement, “LifeScan acknowledges introducing an adulterated and misbranded medical device; failing to provide appropriate notifications and information to the U.S. Food and Drug Administration (FDA), and submitting false and/or misleading reports to the FDA.”

The press release adds, “The basis of this misdemeanor plea was that no one at LifeScan engaged in intentional wrongdoing or intentionally sought to mislead consumers or the government. But LifeScan admits that the SureStep product labeling was deficient, that the company did not properly notify the government of those deficiencies and was slow to remedy them completely.”

“We fully acknowledge those errors and sincerely apologize for them,” said Larsen. “LifeScan products and services have enhanced the lives of millions of people with diabetes. It took years of hard work to earn their confidence and trust. We are committed to learning from this experience and doing everything in our power to be worthy of that trust.”

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